Evaluation of Efficacy & Safety of Ayurvedic formulations Active Antacid Suspension and Active Antacid Tablets in management of acidity and indigestio
- Conditions
- Health Condition 1: K30- Functional dyspepsia
- Registration Number
- CTRI/2017/08/009285
- Lead Sponsor
- Dabur India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 127
1. Male or Female subjects in the age group of 20 years to 50 years.
2. Subjects with greater than or equal to 24% of dyspepsia as per the Hong Kong Index of Dyspepsia
3. Subjects with absence of any clinical or ultrasonographic evidence of organic disease that was accounted for the symptoms
4. Subjects who were willing to sign informed consent and to come for regular followup
examinations as & when required.
5. In the event of subject undergoing treatment for dyspepsia, washout period of 2 days was given prior to inclusion.
1.Subjects with presence of or history of peptic and duodenal ulcers disease or gastric malignancy any gastrointestinal surgery, reflux oesophagitis, any upper or lower G.l. bleeding, with clinical evidence of irritable bowel syndrome or any psychiatric disease.
2. Subjects with clinically diagnosed serious medical or surgical illness (like: Diabetes,
CAD, HT, SLE, Rheumatoid Arthritis, Psoriatic Arthritis) where compliance was difficult.
3. Subjects not willing to follow up for the study visits.
4. Subjects with age range below 20 years and above 50 years
5. Uncooperative Subjects or subjects not willing to sign Informed Consent or giving
consent for study required procedure like endoscopy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To evaluate the efficacy of Antacid Tablet (DRF/AY/4026 ) Antacid Suspension (DRF/AY/5018) in the Management of the Hyperacidity & Functional Dyspepsia in comparison to a marketed comparator. <br/ ><br> <br/ ><br>Timepoint: day 7,14,21,28,35,42
- Secondary Outcome Measures
Name Time Method To evaluate overall subject safetyTimepoint: day 7,14,21,28,35,42